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Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

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ClinicalTrials.gov Identifier: NCT04369469
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 28, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date February 3, 2021
Actual Study Start Date  ICMJE May 11, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
Survival (based on all-cause mortality) at Day 29 [ Time Frame: Baseline, Day 29 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
  • Number of days free of mechanical ventilation at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Duration of intensive care unit stay at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Change from baseline in Sequential Organ Failure Assessment at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Change from baseline in SpO2/FiO2 at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Duration of hospitalization at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Survival (based on all-cause mortality) at Day 60 and Day 90 [ Time Frame: Baseline, Day 60, Day 90 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2020)
  • Number of days free of mechanical ventilation at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Change from baseline in SpO2/FiO2 at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Duration of intensive care unit stay at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Change from baseline in Sequential Organ Failure Assessment at Day 29 [ Time Frame: Baseline, Day 29 ]
  • Survival (based on all-cause mortality) at Day 60 and Day 90 [ Time Frame: Baseline, Day 60, Day 90 ]
  • Duration of hospitalization [ Time Frame: Baseline, Day 29 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
Official Title  ICMJE A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome
Brief Summary This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19 Severe Pneumonia
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Pneumonia, Viral
Intervention  ICMJE
  • Biological: Ravulizumab
    Weight-based doses of ravulizumab will be administered intravenously on Days 1, 5, 10, and 15.
    Other Names:
    • Ultomiris
    • ALXN1210
  • Other: Best Supportive Care
    Patients will receive medications, therapies, and interventions per standard hospital treatment protocols.
Study Arms  ICMJE
  • Experimental: Ravulizumab plus Best Supportive Care
    Interventions:
    • Biological: Ravulizumab
    • Other: Best Supportive Care
  • Best Supportive Care
    Intervention: Other: Best Supportive Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2020)
270
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or females ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent
  2. Confirmed diagnosis of SARS-CoV-2 infection (eg, via polymerase chain reaction [PCR] and/or antibody test) presenting as severe COVID-19 requiring hospitalization
  3. Severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by computed tomography (CT) or X-ray at Screening or within the 3 days prior to Screening, as part of the patient's routine clinical care
  4. Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP])
  5. Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug

Exclusion Criteria:

  1. Patient is not expected to survive for more than 24 hours
  2. Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening
  3. Severe pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias)
  4. Patient has an unresolved Neisseria meningitidis infection
  5. Use of the following medications and therapies:

    • Current treatment with a complement inhibitor or
    • Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization on Day 1
  6. Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever is greater

    Exceptions:

    • Investigational therapies will be allowed if received as part of best supportive care through an expanded access protocol or emergency approval for the treatment of COVID-19
    • Investigational antiviral therapies (such as remdesivir) will be allowed even if received as part of a clinical study
  7. Female patients who are breastfeeding or who have a positive pregnancy test result at Screening
  8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins
  9. Patient who is not currently vaccinated against N. meningitidis, unless the patient agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the patient receives vaccination against N. meningitidis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369469
Other Study ID Numbers  ICMJE ALXN1210-COV-305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexion Pharmaceuticals
Study Sponsor  ICMJE Alexion Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alexion Pharmaceuticals
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP